A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
The Master RAD Protocol is based on the concept that optimal suppression of viral load in vivo will be achieved in patients with rapidly progressing or advanced HIV disease (RAD) using antiretroviral combinations inhibiting viral replication at distinct sites of action. Antiretroviral combinations are chosen with the hypothesis that simultaneous change to as many new agents as possible is necessary to maximally reduce plasma viral load.
In this open-label, multicenter study patients are randomized into 1 of 4 groups based on prior antiretroviral experience. Each regimen consists of 4 drugs...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Your child may be eligible for this study if he or she:
- • Is HIV-positive.
- • Is between the ages of 6 months and 21 years (consent of parent or guardian required if under 18).
- • Has an HIV blood level above 50,000 copies/mL on 2 consecutive occasions, while taking anti-HIV therapy.
- • Has advanced HIV disease or disease progression while receiving 8 weeks or more of continuous unchanged anti-HIV therapy.
- • Is able to receive at least one of the following: RTV, NVP, or NFV.
- • Exclusion Criteria
- Your child will not be eligible for this study if he or she:
- • Is receiving treatment for a serious bacterial, viral, or opportunistic (HIV-associated) infection within 14 days prior to study entry.
- • Has a history of pancreatitis or peripheral neuropathy.
- • Has cancer requiring chemotherapy.
- • Is allergic to the study medications.
- • Is taking certain medications.
- • Is pregnant.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Springfield, Massachusetts, United States
Bronx, New York, United States
La Jolla, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Oakland, California, United States
San Francisco, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Washington, District Of Columbia, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
New Brunswick, New Jersey, United States
Newark, New Jersey, United States
Albany, New York, United States
Brooklyn, New York, United States
Great Neck, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Stony Brook, New York, United States
Syracuse, New York, United States
Durham, North Carolina, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Bayamon, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Newark, New Jersey, United States
Augusta, Georgia, United States
New Orleans, Louisiana, United States
Worcester, Massachusetts, United States
Jacksonville, Florida, United States
Durham, North Carolina, United States
Rochester, New York, United States
Birmingham, Alabama, United States
Mobile, Alabama, United States
Farmington, Connecticut, United States
Fort Lauderdale, Florida, United States
Jackson, Mississippi, United States
Nashville, Tennessee, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Columbus, Georgia, United States
Patients applied
Trial Officials
Andrea Kovacs
Study Chair
Sandra Burchett
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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